Public Statements

PEPFAR

Floor Speech

Mr. COBURN. Mr. President, I have supporting material related to PEPFAR that I will ask to be printed in the Record, which I will deliver to the desk.

PEPFAR's unique contribution has been treatment. By any measure, PEPFAR has been a success. We have helped almost 2 million people with AIDS live longer. We have prevented millions of new infections. We have cared for millions of people more. And we have prevented hundreds of thousands of babies--newborn children--who were born to infected moms from being infected with the HIV virus.

PEPFAR was different from all our previous efforts precisely because we treated it like a disease rather than a development problem. We ran it like a medical program and not a foreign aid poverty program. Rather than funding the usual beltway contractors who like to write reports, give advice, and convene meetings, we put pills in the hands of doctors, nurses, and a legion of community-based health care workers riding out to the bush on mopeds with medicine in their backpacks. We treated people with HIV like patients we can save instead of victims. And we told them the truth about where HIV comes from.

If you go to Nairobi or Soweto or Kampala and ask people what PEPFAR is about, they will tell you it is about treatment. Have we spent billions on prevention? Yes. But ask anyone in Africa what PEPFAR is, and they will say: It is about HIV and AIDS treatment. It was AIDS treatment that was the innovation of PEPFAR. We had been funding prevention messages long before we had PEPFAR, although certainly not to the extent as we did after PEPFAR started. But what was new, what was miraculous, what rocked Africa, was the medical treatment.

And it has worked. It was not easy. With a tiny staff, the AIDS coordinator achieved the impossible--what many had said could not be done--bringing high-tech medical innovation to the lowest tech settings on Earth. It is still just as hard today as it was then, especially as we start in new countries.

The path of least resistance is always the status quo: contractors and ``social marketing'' and reports and ``technical assistance'' and ``capacity building'' and meetings. Without statutory mandates, that path will always look more appealing to people who have been asked to do the impossible. That is why PEPFAR reauthorization could not retreat on its mandated treatment priority.

Take it out of the law, and despite all the rhetoric and good intentions, it will always be easier to fund something else. Maybe treatment would not have been eliminated, but it would have taken a back street, maybe by small cuts, by not building new clinics in the harder places, by letting the shortage of doctors become an excuse to not get creative. The commitment to treatment would have eroded over time, and before we knew it, PEPFAR would have become just another failing foreign aid program like so many others.

It does not matter what people say their intentions are, because people come and go and promises are hard to keep. What matters is what the law requires, and so it is encouraging to be able to assure the American people today that PEPFAR's unique innovation--cutting-edge HIV/AIDS medical care--has been preserved in this bill.

For that, there are a lot of people to thank, starting first with the President and his staff, who first reached out to try to broker this critical compromise. Of course, the bill managers, Chairman Biden and Senator Lugar, and their staff were patient, constructive, and deserve all the thanks in the world. They were quick, thorough, honest, and at all times operated in good faith. Senators Enzi and Burr and their staff were incredible to work with, and their commitment to this cause is commendable.

The compromise language has a number of critical features that make it worthy of passage.

First and most important, the compromise restores the critical focus of PEPFAR on medical treatment. The House bill eliminated the provision in current law that required that 55 percent of all funding go to ``therapeutic medical care'' of people with HIV. The managers' substitute preserves this focus by requiring that ``more than half'' of the money goes to that medical care. This time, the law will also clarify what was meant by ``therapeutic medical care,'' so that there is no longer any confusion that this treatment money can be spent on ARV--antiretroviral--treatment, care for opportunistic infections, and medical monitoring of folks who do not yet need antiretroviral therapy.

Prioritizing treatment is not a radical policy. It is the same policy we have right here in the United States. In this country, this year, we are spending 63 percent of all domestic AIDS funding on treatment and 14 percent on prevention. Prevention is cheap, so you can still make prevention a big priority without spending nearly the money necessary for treatment.

The substitute also restores an ambitious target linked to funding. The original law had the 55-percent allocation, but it also had an ambitious target of treating 2 million people with antiretroviral drugs. The House-passed reauthorization only targeted 3 million people on treatment--a pretty underwhelming figure that meant adding only 1 million people on PEPFAR treatment rolls. That 1 million would have been a 50-percent increase in results, while funding was more than tripling in the bill.

Some have argued that this funding includes a lot of other things besides AIDS and so you cannot make that comparison. That is just not true. The original bill included malaria, it included TB, and it included the Global Fund. So it is an apples-to-apples comparison to say that the funding for AIDS, TB, malaria, and the Global Fund was $15 billion the first time this bill was authorized and that then, in this bill, $50 billion is authorized for those same things at this time.

That is a tremendous amount of money, and the targets for what we expect to achieve with that money must go up at the same rate the funding goes up. The compromise language appropriately links the target number to appropriations. As the funding goes up from the current funding level, the treatment target has to go up by the same percentage above the current goal of 2 million people. That means that if all the money authorized in this bill is appropriated, the number of people treated will exceed more than 5 million. Those extra millions of lives saved are a major accomplishment of the Senate bill. Those are lives. Those are individuals who would otherwise succumb to HIV.

However, the formula does not end there. Treatment costs per patient right now are fairly high--anywhere from $800 to $1,000 per patient. Some drugs are as low as $80 or at most around $200 per person, so we are talking 80 percent of the treatment costs that are not being spent on direct medical care now. That 80 percent represents overhead and infrastructure which should be reduced over time as the efficiencies are built in and clinics are expanded.

To account for that, the compromise language also requires that the target number for treatment increases by the same percent that cost-per-patient decreases over time. This ensures that the cost savings are reinvested right back into treatment rather than diverted to other activities.

Another key element of the compromise is the protection of PEPFAR patients from substandard medicines. From the earliest days of PEPFAR, there were some calling for the United States to buy cheap, copycat drugs for PEPFAR patients, including drugs that were not approved by the FDA or any other rigorous regulatory body of any country. These are drugs we would never treat our domestic patients with here in the United States. This is no abstract threat. Today, under the Orwellian named ``quality assurance'' process at the Global Fund, American dollars may be used to purchase drugs that have met no standard except that they have been put on an application for a WHO prequalification.

When this conflict arose shortly after PEPFAR was first authorized, the President rightly insisted that we would not treat the African AIDS patients like lab rats or guinea pigs. We would treat them with the same standards we treat American patients: They would only receive drugs with FDA approval or equivalent. To help expedite the approval of some international products that were likely safe and effective but had not been through the FDA process, the President established an emergency review process to speed up approval while still ensuring that PEPFAR patients get the same standard of care we expect for our domestic patients. Since then, others have generally agreed that all appropriate safe and effective drugs make it through this new process with proper and direct speed.

In direct contradiction of this more moral approach, the House bill took bilateral PEPFAR programs down the same scary path that the Global Fund has gone. It required that PEPFAR purchase the cheapest drugs available on the world market, without requiring any standard of safety and efficacy. Under such a provision, African patients would have been treated worse than lab rats--receiving drugs that the United States would never use for its patients, never purchase through Medicaid, Medicare, or the Ryan White Care Act.

The bill managers are to be commended for modifying this provision in their substitute to require that drugs purchased by PEPFAR have FDA approval or its equivalent in other developed countries. We can all breathe a little easier as we seek to put 5 million people on ARVs. We want those 5 million people to thrive as long as possible on first-line drugs before they experience a treatment failure. You should not be relegated to unsafe drugs just because you are poor and living in Africa.

There are quite a few other improvements in this substitute bill that the managers and the President helped to broker, but I will not take any more time. Suffice it to say that most of my outstanding concerns have been met through our negotiations, and I am confident that PEPFAR's success in the future is no longer in jeopardy.

PEPFAR was not broken. It did not need fixing. It just needed reauthorization. The managers' substitute does that. I am confident that lives are going to be saved because of the good faith in the bill and of the bill managers and the President and my other colleagues who are associated with it.

Mr. President, I ask unanimous consent to have the supplementary material I referred to printed in the Record.

There being no objection, the material was ordered to be printed in the Record, as follows:

From Good Intentions to Bad AIDS Policy: The Moral Hazards of Redesigning PEPFAR(By Daniel Patrick Moloney)

The President's Emergency Plan for AIDS Relief (PEPFAR) has received praise from across the political spectrum, both for its principles and for its successes in fighting HIV/AIDS in some of the world's poorest countries. Announced by President George W. Bush in the 2003 State of the Union Address, PEPFAR fights HIV/AIDS primarily in countries with generalized epidemics. These countries are mostly, though not exclusively, in Africa.

PEPFAR's successful track record is a result of its focus on three points:

Treating those infected with HIV,

Preventing new HIV infections, and

Ensuring, through bilateral programs, that assistance is in accord with U.S. policy.

Bills under consideration in the U.S. House and Senate (H.R. 5501 and S. 2731) represent significant departures from the current law. These bills are hugely expensive, and would take existing U.S. policy off its present, successful course.

Rather than simply reauthorizing PEPFAR, Congress seeks to rewrite it, vastly expanding funding while removing structural guidance that stipulates how it is apportioned. The structure of the original PEPFAR law was essential for keeping it focused on its prevention and treatment objectives. The congressional bills fail to do this. Both more than triple the $15 billion cost of the original program, yet neither adjusts the targets of the program to reflect this increase. Instead, both propose to spend tens of billions of dollars on projects not directly related to the fight against HIV/AIDS. This proposed spending duplicates existing programs, and diverts resources into social engineering projects at odds with the values of many Americans.

To achieve PEPFAR's goal, policy must continue to be guided by strong requirements that will direct funding toward effective prevention and treatment strategies, rather than a diffuse set of general development goals.

From Good Intentions to Good Policy: The Original Design of PEPFAR. As proposed by President Bush in 2003, PEPFAR was built around three priorities:

Providing medicine to treat those who have HIV/AIDS in those countries where the disease affects the general population,

Funding local programs that aim to prevent new HIV infections, and

Providing palliative care to those suffering from HIV/AIDS, including children orphaned as a result of HIV-infected parents.

To justify its ambitious agenda and $15 billion price tag, the original law used three structural features to keep the program focused on its priorities: ambitious targets, spending requirements, and an emphasis on bilateral agreements.

The law set ambitious targets for the number of people in its treatment, prevention, and care programs. These goals were so ambitious that they could not be met were the money lost to waste or corruption, or simply diverted to other development activities not directly providing treatment, care, or prevention of HIV/AIDS.

The law also provided strong guidance so that the money would be spent in proportion to the law's priorities. It did this in two distinct but related sections of the law. The first, a ``Sense of Congress'' resolution, declared that 55 percent of the funds should be spent on medicine and treatment, 10 percent on orphans and children affected by HIV, 20 percent on prevention programs, and 15 percent on palliative care. This gave the Global AIDS Coordinator some idea how to balance the competing ends of the bill. The next section, which actually allocated the funds, made the first two elements of this nonbinding resolution into binding spending requirements. Though it did not make binding that 20 percent be spent on prevention, it did require that one-third of funds spent on prevention be spent on programs that promote abstinence outside of marriage and fidelity within it. By requiring that the money be spent according to these specific percentages, rather than authorizing particular dollar amounts, the law ensured that its priorities would always be implemented in the same proportions, even were Congress later to appropriate funds at amounts different than the law had authorized.

The law required that PEPFAR deliver aid through bilateral arrangements with each of the partner countries, rather than through multilateral organizations. This procedural safeguard gave the U.S. its best opportunity to make sure the funds were spent on its priorities. It was consistent with the President's belief that welfare and aid programs work best when they support civil society, rather than supplant it with an international bureaucracy.

The bills in the House and the Senate undermine these principles. They set goals too low for their budgets, remove most of the spending mandates under the guise of ``flexibility,'' and add radical new agendas on which the unstructured and abundant funds are to be spent.

Funding Should Fit Program Goals. In asking Congress to reauthorize PEPFAR for the next five years, the Bush Administration sought to increase the budget by 100 percent to $30 billion over five years. However, the President sought to increase its goals by a mere 20 percent to 70 percent (depending on the criterion) over that period. Some Members of Congress have complained that the Administration's goals are too low to justify doubling the funding. They note that the program is on track to meet its original goals of 2 million treated, 7 million infections prevented, and 10 million people in care, while staying close to its original budget of $15 billion-$18 billion. Given such a history, the Administration's moderately increased goals should require only moderately increased funding, particularly now that so much early infrastructure has been laid in the focus countries and some efficiencies of scale may be expected.

The Administration defends its lower goals on the grounds that they are realistic given local infrastructure. It also notes that its proposed goals represent a U.S. commitment to treat a number of people equal to the commitment of all other aid-donor nations combined. For the U.S. to treat more would not demand enough of the world community. It also expresses doubts that in 2013 there will be as many people to be treated in the focus countries as some of its critics predict.

If the Administration's request is disproportionate to its goals, the bills in the House and the Senate are even more so. Both bills add an additional $20 billion to the President's request--more than the entire first five years of the program--while barely changing the Administration's underwhelming new goals. The bills authorize up to $9 billion to fight other diseases common in Africa (i.e., tuberculosis and malaria), and they authorize billions more in contributions to the Global Fund to Fight AIDS, Tuberculosis, and Malaria. After taking all these into account and after assuming full funding of the bills' priorities, the Congressional Budget Office concluded that the bills would still have at least $15 billion left over. To date, no one in either chamber has adequately explained what will be done with the ``extra'' billions.

Congress could improve the fit between PEPFAR's funding and its goals by making the latter more ambitious. For example, Senators Tom Coburn (R-OK), Jon Kyl (R-AZ), Saxby Chambliss (R-GA), and Richard Burr (R-NC) have introduced S. 2749, the Save Lives First Act of 2008. This bill would set PEPFAR's treatment goal at providing HIV/AIDS treatment and pre-treatment medical monitoring to 7 million people, about one-half of them in sub-Saharan Africa--an increase from 3 million in the House and Senate bills. It would also reinstitute the provision in current law allocating at least 55 percent of all PEPFAR funds to treatment. To treat that many people is estimated to cost between $8.4 billion and $11.5 billion.

Higher goals require more money, but the draft bills' proposed goals for treatment, prevention, and care are not by themselves high enough to justify even the Administration's $30 billion price tag. Activities extraneous to the original program are likely to make up the difference. Whether Congress decides to increase PEPFAR's treatment goals along the lines of the Save Lives First Act, or whether it sticks with its current goals, a $50 billion budget would still include extra billions likely to be spent on purposes irrelevant to PEPFAR.

``Flexibility'' Means Blank Check Worth Billions. The original PEPFAR law contained binding requirements that 55 percent of all funds be spent on medical treatment, and 10 percent on orphans and vulnerable children. It further required that 33 percent of the prevention funds be spent on abstinence and fidelity programs. The spending restrictions (except for that regarding orphans) have been criticized, both by NGOs that disagree with U.S. priorities, and by bureaucrats who implement the program.

Both the House and the Senate strip out these funding requirements for prevention and treatment. (The Senate bill even strips out most of the nonbinding ``Sense of Congress'' resolutions of the original law.) The House bill gives the Global AIDS Coordinator complete control over 55 percent of the funding, and the Senate bill writes a blank check for 90 percent of the funds. Beyond this, the bills provide some vague guidance, but not hard requirements, on how money will be spent. The Global AIDS Coordinator is left to prioritize the multiple goals and agendas of the bills.

New Funds and Radical New Agendas. The proposed legislation expands the activities eligible for PEPFAR funding well beyond the scope of the original program, offering some clues about how its ``extra billions'' could be spent. Some of these new agendas are duplicative of other foreign aid programs and are irrelevant to fighting HIV/AIDS. For example, the legislation promotes micro-finance, education, general health care, and food security, among other new programs.

The bills also add a number of radical new agendas that change the focus of PEPFAR, are at odds with the values of many Americans, and trample on the cultural values of the partner countries. For example, the bills before Congress make it U.S. policy to teach safer drug-use techniques to injection drug users, and safer sex techniques to prostitutes, injection drug users, and men who have sex with men (MSM). The original law made no special provisions for outreach to these populations, reflecting the fact that infections among these risk groups are marginal to the generalized epidemic in subSaharan Africa, as opposed to the epidemics concentrated among these groups in countries such as Russia and Thailand. Where it did mention them, the original law sought to eradicate prostitution and to encourage injection drug users to stop, recognizing that public health policy should not enable such high-risk behavior but seek to end it. In a clear policy reversal, the proposed legislation strips out the original commitment to eradicate prostitution, and makes PEPFAR dollars available to activities intended to make illicit drug use ``safer.'' Not coincidentally, it also allows PEPFAR to expand to include more focus countries in Europe and Asia where the epidemics are concentrated among prostitutes and drug users.

The bills would also commit the U.S. to altering the relations between men and women in developing countries to reflect the values of Western gender activists. The bills encourage U.S. intervention on sensitive cultural topics that are not scientifically demonstrated to have direct impacts on rates of HIV/AIDS morbidity or mortality, but very well might offend those whom U.S. policy is designed to help. Whatever merits these provisions might have as aspirations, they were not in the original bill, they would do nothing to stop the AIDS emergency in sub-Saharan Africa, and they would commit the U.S. to agendas that are likely to be unpopular in partner countries.

Conclusion: Compassionate Aid Is Effective Aid. The three structural features of the original law--ambitious targets, spending restraints, and an emphasis on bilateral agreements--have helped PEPFAR stay on target. In the process, the U.S. has created a strong precedent for combating HIV/AIDS in poor countries with generalized epidemics. PEPFAR's commitment to abstinence and fidelity programs, which was and is still ridiculed by many activists and others, is now recognized to have a measurable impact on HIV infection rates.

Rather than write a blank check to an unelected bureaucracy, Congress should retain firm control over PEPFAR, which touches on such delicate issues as sex, marriage, and the relations between men and women. Congress should insist that PEP-FAR retain its focus on preventing new HIV infections and treating those infected with HIV/AIDS. PEPFAR should not duplicate the efforts of America's other aid programs. Lawmakers should insist that the funds authorized and appropriated for PEPFAR will not support activities irrelevant to fighting HIV/AIDS in countries with generalized epidemics. Congress should authorize funds for PEPFAR at a level appropriate to its central goals. If Congress wishes to fund other activities, it should do so by increasing the budget for other assistance programs rather than diffusing PEPFAR's focus.

America's PEPFAR partners are waiting on congressional reauthorization before setting their own budgets, putting pressure on Congress to move quickly. Hasty passage of the existing House and Senate bills, however, would not allow them to make their plans either, since so many funding decisions would still be left to the discretion of the Global AIDS Coordinator in the next administration, and subject to the annual appropriations process and the lobbying of NGOs. With lives at stake, strategic efficiency and effectiveness are paramount. Ambitious goals, clear spending directives, and a reassertion of successful U.S. policies will maintain the structure and proportion that have leveraged Americas generous intentions into a highly effective policy.

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Myths v. Facts--Re: Global AIDS Legislation (PEPFAR)

Myth: ``We Can't Treat Our Way Out of This Epidemic.''

Fact:

We have to walk and chew gum--we must prevent future infections but we must respond to the desperate and dying TODAY.

Prevention efforts may prevent new infections, and therefore prevent FUTURE treatment need, but prevention efforts do nothing to abate the treatment need in the next 5 years, which is the time period the reauthorization bills address.

Treatment need is determined by numbers infected 5-10 years ago.

This argument is like going into a post-Katrina New Orleans and spending most of the relief funds on building better levies to prevent a future disaster rather than rescuing the people waving frantically on rooftops for help.

Obviously both need to be done, but no one would claim that it was somehow more humane to focus more effort and funding on the future prevention than the immediate humanitarian disaster.

Treatment, is prevention. Treatment prevents new infections several ways:

It requires dramatic scale-up of diagnostic screening--meaning we will identify most infected people.

It will give us the opportunity to do education and prevention messaging with the people who are transmitting HIV rather than wasting money on mass media campaigns targeting mostly uninfected people. Nobody ever got HIV from someone who wasn't infected with HIV.

It identifies pregnant women with HIV so that their babies can be saved from infection.

It lowers viral load. There are quite a few studies out now showing that reduced viral load dramatically reduces the transmission of the virus.

Myth: Flexibility--``Earmarks'' or ``Allocations'' dictating how much money has to be spent on a certain activity are too inflexible and don't allow countries to respond to their needs appropriately.

Fact:

The allocations are not country-specific, they apply to the whole pot of money. If one country needs to spend less money on treatment, there are other countries where treatment is particularly expensive and can use the extra.

Other donors such as the Global Fund can come in and fund other priorities for the country--the American people are committed to treatment being the priority for PEPFAR.

Public health has taught us how to control infectious disease and it doesn't require flexibility. It requires a formula--find every case, treat every case, work with every case to find other cases and prevent transmission to new cases. This doesn't change no matter what the circumstances on the ground are.

This argument is disingenuous--the other side only wants to eliminate the allocations that take money away from beltway contractors--those for treatment and abstinence, because those contractors don't do treatment or abstinence. The other allocations have been left in the bill, and in fact, new ones added in the House version. You can't simultaneously criticize allocations but add in new ones.

Myth: Drug prices have gone down so we don't need to reserve as much for treatment costs anymore to meet our treatment targets.

Fact:

If it's now cheaper than expected to meet targets, then we should raise our targets to save and treat more people. We only are treating a small fraction of people in need of treatment in the developing world.

Myth: Eliminating baby AIDS is unrealistic.

Fact:

Dramatic gains are seen when universal testing of pregnant women and newborns is provided and appropriate prophylaxis of infections that are identified through that testing.

In states in the U.S. that have adopted this standard of care, new cases have been virtually eliminated.

In Botswana, a country that used to have HIV infection rates as high as 50% of child-bearing-aged women, they instituted these policies. Now 92% of pregnant women are being tested, and the drop in HIV+ mothers delivering infected babies dropped from 35% to 4% from 2004-2007, with 13,000 HIV-infected moms being identified annually.

A recent study, the largest to date, just came out with findings that 99 percent of babies were born uninfected if an infected mother was diagnosed and proper treatment was administered.

However, a World Health Organization report found that access to AIDS drugs is severely limited in developing countries, with fewer than 10 percent of pregnant women with HIV in those countries having access to medication.

As a result, about 1,800 babies become infected with HIV each day. Prevention of mother-to-chi1d-transmission (PMTCT) is cheap per life saved: Estimated cost of PMTCT drugs to support treatment of (1) mother/child pair is US$167 (generics) and US$318 (branded).

We haven't even come close to meeting the need in PEPFAR focus countries.

Estimated 1.15 million pregnant women with HIV/AIDS living in PEPFAR countries.

In 2006 PEPFAR proved ARV Prophylaxis to only 294,000 (25.5%).

And now PEPFAR is expanding beyond the focus countries to other countries--the need just will keep growing:

Estimated 2.1 million pregnant women estimated to be living with HIV/AIDS in developing countries (1.7 million in sub-Saharan Africa -85%).

Of the estimated 2.3 million (1.7-3.5 million) children under the age of 15 years living with HIV, well over 90% are thought to have become infected through mother-to-child transmission.